Trial Information

Phase I/II Trial Of Super-Selective Intraarterial Infusion Of Erbitux (Cetuximab) And Avastin (Bevacizumab)For Treatment Of Relapsed/Refractory Intracranial Glioma In Patients Under 22 Years Of Age

The experimental aspects of this treatment plan will include:

1. Subjects will first be treated with Mannitol prior to chemotherapy infusion (Mannitol
25%; 10 mL over 2 minutes) in order to disrupt the blood brain barrier. This technique
has been used in several thousand patients in previous studies for the IA delivery of
chemotherapy for malignant glioma. We have used this without complication in our
patients from our Phase I protocols as well.

2. To treat patients <22 years of age with recurring or relapsing glioma with a single
intraarterial delivery (SIACI) of Cetuximab and Bevacizumab. Our Phase I trials have
demonstrated the safety of SIACI delivery of these drugs in adults. This trial will
focus on the safety and efficacy in patients <22 years of age.

2. Patients must have at least one confirmed and evaluable tumor site.

*A confirmed tumor site is one in which is biopsy-proven with the exception of
brainstem glioma which will be eligible with radiographic diagnosis. NOTE:
Radiographic procedures (e.g., Gd-enhanced MRI or CT scans) documenting existing
lesions must have been performed within three weeks of treatment on this research
study.

3. Patients must have a Karnofsky or Lansky performance status 70%. Karnofsky is used
for patients older than or equal to the age of 16 years and Lansky for those under 16
years old and an expected survival three months.

4. No chemotherapy for three weeks prior to treatment under this research protocol and
no external beam radiation for eight weeks prior to treatment under this research
protocol.

5. Patients must have adequate hematologic reserve with absolute neutrophils greater
than or equal to 1000/mm3 and platelets greater than or equal 100,000/mm3.

6. Pre-enrollment chemistry parameters must show: bilirubin less than 1.5X the
institutional upper limit of normal (IUNL); AST or ALT less than 2.5X IUNL and
creatinine less than 1.5X IUNL.

7. Pre-enrollment coagulation parameters (PT and PTT) must be less than 1.5X the IUNL.

8. Concomitant Medications:

Growth factor(s): Must not have received within 1 week of entry onto this study.

Steroids: Systemic corticosteroid therapy is permissible in patients with CNS tumors
for treatment of increased intracranial pressure or symptomatic tumor edema. Patients
with CNS tumors who are receiving dexamethasone must be on a stable or decreasing
dose for at least 1 week prior to study entry.

9. Patients of reproductive age must agree to use a medically effective method of
contraception during and for a period of three months after the treatment period. A
pregnancy test will be performed on each premenopausal female of childbearing
potential immediately prior to entry into the research study.

10. Patients or their parents/guardians must be able to understand and give written
informed consent. Informed consent must be obtained at the time of patient
screening.

11. Because of known concerns with Avastin and wound healing, craniotomy patients are
eligible for the treatment if they have had a craniotomy greater than two weeks prior
to IA therapy. Craniotomy or major procedure after SIACI Avastin therapy should wait
4 weeks. Minor surgeries may be performed after two weeks.

Criteria for Exclusion:

1. Previous treatment with Avastin and Cetuximab

2. Females who are pregnant or lactating.

3. Females of childbearing potential and fertile men will be informed as to the
potential risk of procreation while participating in this research trial and will be
advised that they must use effective contraception during and for a period of three
months after the treatment period. If they do not agree, they will be ineligible for
the study.

4. Patients with significant concurrent medical or psychiatric conditions that would
place them at increased risk or affect their ability to receive or comply with
treatment or post-treatment clinical monitoring.

Type of Study:

Interventional

Study Design:

Outcome Measure:

Toxicities

Outcome Description:

The descriptive frequency of subjects experiencing toxicities will be tabulated. Toxicities will be assessed and graded according to the NCI Common Toxicity Criteria, version 4.0. Exact 95% confidence intervals around the toxicity proportions will be calculated to assess the precision of the obtained estimates.

Outcome Time Frame:

2 Years

Safety Issue:

Yes

Principal Investigator

Jeffery Greenfield, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Institutional Review Board

Study ID:

1202012214

NCT ID:

NCT01884740

Start Date:

June 2013

Completion Date:

January 2018

Related Keywords:

Glioblastoma Multiforme

Fibrillary Astrocytoma of Brain

Glioma of Brainstem

Anaplastic Astrocytoma

Pilomyxoid Astrocytoma

Mixed Oligodendroglioma-Astrocytoma

GBM

AA

FA

PXA

AOA

Astrocytoma

Glioblastoma

Glioma

Oligodendroglioma

Name

Location

We are a Cancer Social Network, Resource Directory & Education Hub supporting all those affected by cancer. knowcancer.com is intended to be solely for informational purposes and should not be a substitute for professional medical advice, diagnosis or treatment.